Multicompartment containers adapted for initially holding in separate compartments, two or more substances for materials such as medicaments, either liquid or dry, and a diluent or carrier solution therefor, have been known and used.
Specific examples of containers of this general nature are disclosed in U.S. patents issued to Arthur E. Smith, U.S. Pat. Nos. 2,653,610 and 2,653,611. These two patents disclose broadly the concept of a two compartment container for medicament products wherein a dry powder medicament and diluent therefor are initially separated or isolated from one another, and means are provided for so activating the container as to mix the dry and liquid components for subsequent utilization in known manners.
This prior art and particularly in the principal embodiment of U.S. Pat. No. 2,653,610 includes a container such as a bottle having a body portion within which the diluent is housed and a reduced neck portion 13. The dry powdered or crystalline medicament or drug is housed in a stopper which is inserted in the top opening of the bottle. A closure is placed over the stopper to complete the package. When it is desired to prepare, for example, a fresh drug solution, the stopper or top and a stem mounted therebelow within the dry medicament container are adapted to be pushed or forced downwardly. The bottom of the dry medicament container consists of a fracturable diaphragm. When the top and stem are pushed downwardly, the diaphragm is fractured and the stem, together with a section of the fractured diaphragm fall into the diluent solution in the container.
In this known type of container, it will be seen that the resultant mixture is possibly contaminated by a portion of the fractured or ruptured diaphragm together with the stem which are conjointly displaced and fall into the liquid diluent. Such contamination is undesirable and can result in difficulties of utilization of the liquid mixture and/or cause a deterioration or other type of contamination thereof.
It is also to be noted that the dispensing closures of these two Smith patents are of a construction which prevents the diluent and dry medicament product to be packaged or filled separately, and further the structure in these patents prevents inspection of the independent compartments prior to assembly of a dry medicament compartment within a collapsible bag such as a plastic I.V. container. The separate packaging concept which permits the separate filling prior to joinder of the two compartments, and permits a separate inspection of the independent compartment, further increases the shelf life of the overall package and the material or substance contained therein by isolating the diluent and dry drug in a guaranteed fashion.
As aforementioned, the present invention is directed to a multiple compartment, preferably large volume, I.V. container having new and improved structure and outstanding improvements in the overall formation and subsequent use thereof.
In the preferred embodiment hereinafter described in detail and as shown in the drawings, the basic concept of the invention is disclosed. A separate dry medicament or drug container is formed by utilizing an open-ended cylinder which can consist of a plastic material, or a composite of a plastic material cylinder within which a glass cylinder is inserted, the cylinders being open-ended. A resilient closure plug is fitted into the interior of the inner cylinder in a composite structure, or the single plastic cylinder, and forms a bottom closure therefor. The material is composed of a suitable elastomeric material such a rubber, neoprene, plastic, butyl rubber and the like and has a sufficient thickness and resilience to initially seal the bottom of the open end cylinder and permit introduction of, for example, a dry medicament material into this container as a separate medicament holding container. The use of the plastic outer cylinder or sleeve, or a plastic exterior surface in a composite construction, facilitates adhering of this container in an opening into an I.V. container which, as is well known, is generally of a flexible transparent plastic material. The adhesion or fixing can utilize suitable adhesives, heat sealing and/or other known methods. When a glass inner cylinder is utilized a greater immunity to reaction with certain medicaments is obtained.
An upper plug of a suitable structure and material is inserted in the interior of the top sleeve above the medicament container therein. This compartment accordingly is variable for containment of varied amounts of materials. A plunger which can vary in construction, and having a push rod adjoined thereto, and which extends outwardly from the medicament compartment or container, upon being depressed will displace the bottom plug or seal by compression of the air or contact with the top of the medicament. The plug closing the bottom of the compartment is accordingly discharged into the diluents containing bag and it is to be noted that no fragmentation of the container results. The materials used permit separate filling of the dry medicament compartment or container, which is thereafter placeable within the top opening of the I.V. bag and appropriately sealed therein. As will appear hereinafter, certain modifications can be utilized, such as for example the use of a lyophilization plunger or upper stopper can be used. The push rod and stopper can be so joined that the plunger, following actuation to discharge material into the bag, will still serve as a seal to maintain complete sterility of the material within the bag following mixing.
Other objects and advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein there is shown and described preferred embodiments of the invention, simply by way of illustration of currently preferred and contemplated modes for carrying out the invention. As will be realized, the invention is susceptible to other and specific embodiments, materials, and details are capable of modification in various, obvious respects, all without departing from the invention. Accordingly the drawings and description are to be regarded merely as illustrative in nature, and not as restrictive.